Balloon catheters and methods for manufacturing balloons for balloon catheters

ABSTRACT

Catheters, balloons, and methods of manufacturing balloons for balloon catheters using lasers are disclosed. A catheter with a shaft sized for use with a 0.014 inch guide wire includes a polymeric balloon having a body portion with an inflated outer diameter of more than 6 millimeters. An inflatable balloon includes an inflated outer diameter to inner waist diameter ratio of 12.5 to 1. An inflatable polymeric balloon that has a body portion with two regions that have different molecular orientations is also provided. A method of processing an elongate polymeric material includes heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material. A method of manufacturing a balloon includes heating and longitudinally stretching a first and second portion of an elongate polymeric tube to form first and second end portion. The remaining body portion is radially expanded to form the balloon.

TECHNICAL FIELD

This invention relates to balloons for medical devices such as ballooncatheters, and also to manufacturing such balloons using a heating andstretching process that uses laser energy for the heating.

BACKGROUND

Balloon catheters are used to perform various medical procedures withinthe body. One example is a percutaneous transluminal coronaryangioplasty (PTCA). To perform a PTCA, a physician guides a ballooncatheter through the vascular system over a guide wire until thecatheter's balloon is positioned across a thrombus, commonly referred toas a lesion, that has reduced or completely blocked blood flow through avessel. Once placed, the balloon is inflated radially, or that is,outwardly, to a pre-determined diameter, for example 9 millimeters, toreestablish blood flow through the vessel.

To maneuver a distal end of the balloon catheter through the vascularsystem to treat a lesion that has a very small opening requires theballoon catheter to have a small crossing profile, which is the largestcross-sectional diameter of the balloon portion of the balloon catheter.One portion of the crossing profile is the diameter of the catheter'sshaft, which must be large enough to allow a guide wire to pass freelythrough a guide wire lumen in the shaft in a longitudinal direction.Catheters that use a guide wire with a larger diameter will have alarger catheter shaft and vice-versa. Existing catheters typically useguide wires that have cross-sectional diameters in the range of fourteenthousandths of an inch (0.014) up to 35 thousandths of an inch (0.035).Smaller guide wires make it easier to maneuver the balloon catheterthrough the body. Consequently, many doctors that perform cardiacprocedures prefer using balloon catheters with a 0.014 inch guide wire.

Another portion of a balloon catheter's crossing profile is thethickness of the folded balloon, particularly at the balloon's foldedcone and waist portions. Catheter balloons typically have a body portionnear the center of the balloon, which is the portion of the balloon thatexpands. The balloon's waist portions are located at the balloon'sproximal and distal ends, and the cone portions are located between theballoon's body portion and the waist portions. Typically, the wallthickness of the entire balloon is restricted to the dimensions of theoriginal tubing material, or parison, from which the balloon is formed.Thus, an overall reduction in the wall thickness of the parison toreduce the thickness of the cone and waist portions will also result ina similar reduction of the wall thickness of the parison in the bodyportion. A reduced body portion wall thickness, however, limits thediameter to which the balloon may be inflated while maintaining asatisfactory hoop strength, which is a measure of a balloon's ability towithstand internal pressure. Consequently, there have been continuingefforts to form balloons made of materials suitable for cardiacprocedures, such as Nylon 12, PEBAX, PET, and PEEK, that have largeinflation diameters, for example 9 millimeters, and small crossingprofiles.

One method of forming balloons with body portions that have a greaterwall thickness and waist portions that have a reduced wall thickness isto physically remove, or grind away, the undesired thickness of thewaist portions. This method may be performed, for example, by using alaser ablation process utilizing UV excimer lasers or ultrashort lasers.The physical removal of the wall, however, has not been able to producea balloon that has an inflation diameter of greater than six millimetersfor use on a catheter having a 0.014 inch guide wire.

The wall thickness of a polymer tube may also be changed by astretching, or “drawing down,” process. Using this process, the wallthickness of the tubing may be locally reduced in the cone and waistportions of the balloon. Heating is advantageous during the stretchingprocess because polymers have certain thermophysical characteristicsthat cause them to soften and flow upon heating. Thus, with the use ofheat, it is possible to target a specific portion of a polymer tube forstretching. Various heating methods are used to heat polymer tubes forstretching. These methods include passing a polymer tube through aheated ring and putting the tube in a hot oil or hot water bath. Thesemethods, however, result in a large heating area and do not provide theability to target small areas of the polymer tube for stretching. Forexample, the heating area of a heated ring is typically greater thanfive millimeters along the axial direction. The heating area of a hotoil or hot water bath is even greater. Thus, these methods thatessentially provide heat from the outside of the tube are not suitableto vary the amount of stretching of a coronary balloon, which istypically one to two centimeters in length (the cone and waist portionsbeing only a few millimeters in length). Moreover, it takes severalseconds to change the amount of heat applied to the polymer tube usingthese methods.

SUMMARY

The invention features balloons, catheters, and methods of manufacturingballoons for balloon catheters using lasers. The use of lasers forheating allows small areas of a polymer tube to be targeted forstretching. Lasers also allow the heat to be delivered uniformlythroughout the bulk of the polymer tube instead of relying on heatconductivity from the tube's outer layers. In addition, lasers providethe ability to instantaneously change the amount of heat applied duringthe process to precisely vary the amount of stretching in the variousportions of the polymer tube. The ability to instantaneously change theheat provided during stretching also allows the molecular orientation ofthe balloon to be varied throughout its length.

In one aspect, the invention features a method of manufacturing aballoon for a balloon catheter. The method includes heating andlongitudinally stretching a first portion of an elongate polymer to forma first reduced diameter portion of the tube that serves as a first endportion for the balloon. A second portion of the tube is heated andlongitudinally stretched to form a second reduced diameter portion ofthe tube that serves as a second end portion for the balloon that isopposite the first end portion. A body portion located between the firstand second end portions is expanded radially to form the balloon.

In embodiments, the heating of the first and second portions may beperformed by a laser, which may emit a beam in the infrared frequencyrange to heat the first and second portions. In some implementations,the elongate polymeric tube may have a uniform diameter before themethod is performed.

The balloon may have an inflatable body portion with sufficient hoopstrength for use in an angioplasty procedure. The inflated outerdiameter of the balloon may be more than about six millimeters, forexample, about 9 millimeters. In implementations where the first endportion of the balloon includes a first waist section and the second endportion of the balloon includes a second waist section, the first andsecond waist sections may have an inner diameter such that the balloonmay be affixed to a catheter shaft that has an inner lumen sizedappropriately to accommodate a guide wire having a diameter of at mostabout 0.014 inches. The first and second waist sections may have aninner diameter that is, for example, no more than 0.028 inches. In someimplementations, the formed balloon may have an inflatable body portionthat has a longitudinal length suitable for use in an angioplastyprocedure. In other implementations, the inflatable body portion of theballoon may have a longitudinal length of no more than about 30millimeters.

In another aspect, the invention also features a catheter that includesan elongate shaft having a lumen that extends longitudinally through theshaft. The lumen is sized appropriately to accommodate a guide wirehaving a diameter of at most about 0.014 inches. An inflatable polymericballoon is affixed circumferentially about the shaft near the distal endof the shaft, and has an inflated outer diameter of more than about 6millimeters.

In embodiments, the balloon may be formed by heating and longitudinallystretching a first portion of an elongate polymeric tube to form a firstreduced diameter portion of the tube that serves as a first end portionfor the balloon, and heating and longitudinally stretching a secondportion of the tube to form a second reduced diameter portion of thetube that serves as a second end portion for the balloon that isopposite the first end portion. A body portion located between the firstand second end portions may be expanded radially to form the balloon. Insome implementations, before the balloon is formed, the elongatepolymeric tube has a uniform diameter. The heating of the first andsecond portions may be performed by a laser, which may emit a beam inthe infrared frequency range to heat the first and second portions.

In some embodiments, the balloon's body portion may have an inflatedouter diameter of 9 millimeters and may be suitable for use in anangioplasty procedure. The balloon may have a first end portion thatincludes a first waist section and a second end portion that includes asecond waist section. The first and second waist sections may have aninner diameter of no more than about 0.028 inches.

In another aspect, the invention features an inflatable polymericballoon for a balloon catheter. The balloon includes a waist portionhaving an inner diameter that fits circumferentially around and isaffixable to an elongate shaft that has an inner lumen sizedappropriately to accommodate a guide wire having a diameter of at mostabout 0.014 inches. The balloon's body portion has an inflated outerdiameter, the ratio of the outer diameter of the body portion to theinner diameter of the waist portion being at least 12.5 to 1.

In embodiments, the balloon may be formed by heating and longitudinallystretching a portion of an elongate polymeric tube. The polymeric tubefrom which the balloon is formed may have a uniform diameter before theheating and stretching. The heating of the tube may be performed by alaser, which may emit a beam in the infrared frequency range. In someembodiments, the inner diameter of the waist portion may be about 0.028inches or less. The balloon may also have an inflated outer diameter ofmore than about 6 millimeters, for example, about 9 millimeters.Further, the balloon may have an inflatable body portion with sufficienthoop strength for use in an angioplasty procedure.

In another aspect, the invention features a method of processing anelongate polymeric material for use in a medical device that is placedinside a body. The method involves heating a portion of the polymericmaterial with a laser while longitudinally stretching the portion of thepolymeric material.

In embodiments, the laser may emit a beam in the infrared frequencyrange to heat the polymeric material, which may be Nylon 12, PEBAX, PET,or PEEK. The laser may have a heating area of approximately twomillimeters or less. The method may also include cooling the heatedportion of the polymeric material after it has been longitudinallystretched to the desired dimension. A control system may be used tocontrol the heating and stretching of the polymeric material.

In another aspect, the invention features an inflatable balloon for aballoon catheter constructed of a single polymeric material and havingfirst and second regions. The polymeric material in the first section isoriented in a fashion that results from the balloon's body portion beingstretched while being heated by a laser. The polymeric material in thesecond region is oriented differently from the first region.

In embodiments, the balloon may have an inflatable body portion that hasa longitudinal length suitable for use in an angioplasty procedure. Inother implementations, the balloon may have a longitudinal length of atmost about 30 millimeters. The laser may emit a beam in the infraredfrequency range to heat the polymeric material, which may be Nylon 12,PEBAX, PET, or PEEK.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a diagram of an elongate polymer tube and a system forprocessing the elongate polymer tube.

FIGS. 2A and 2B provide an illustration of the heating and stretching ofthe polymer tube during the process described in FIG. 1.

FIGS. 3-8 are successive diagrams of an elongate polymer tube as it isprocessed to form a balloon for a balloon catheter.

FIG. 9 is a cross-sectional view, along a longitudinal plane, of adistal portion of a balloon catheter that has a balloon manufacturedusing the system and methods described in FIGS. 1-8.

FIG. 10 is a conceptual diagram of a balloon manufactured using theheating and stretching system and methods of FIGS. 1-8, and thatillustrates the molecular orientation of polymeric material in a bodyportion of the balloon.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

FIG. 1 shows an elongate polymer tube 10 being processed to produce, forexample, a balloon for a balloon catheter (not shown). In this example,the polymer tube 10 is being released from an unwinding spool and motionsystem 12 at a selected speed, as indicated by arrow A. At the sametime, the polymer tube's leading end 26, which is secured to a windingspool system 14, is being pulled by the winding system 14. Two laserdevices 16 and 17 each direct a laser beam 18 toward a small targetportion 22 of the polymer tube 10 to quickly heat the target portion 22to a desired elevated temperature for stretching. The speed, indicatedby double arrows B, at which the winding system 14 pulls the securedleading end 26 of the polymer tube 10 away from the unwinding spool 12is selected to be greater than the speed at which the unwinding spool 12is releasing the tube 10. Thus, the winding system 14 exerts alongitudinal pulling force on the polymer tube 10, thereby stretchingthe tube at the heated target portion 22 and reducing thecross-sectional diameter and wall thickness of the tube's target portion22.

In this example, it will be appreciated that a leading portion 24 of thetube 10 located between the tube's leading end 26 and the target portion22 has already been heated and stretched, whereas a trailing portion 20of the tube 10 located between the tube's target portion 22 and theunwinding spool 12 has not yet been heated and stretched. Therefore, theleading portion 24 of the tube 10 is shown to have a smallercross-sectional diameter than that of the tube's trailing portion 20.

A temperature sensor 28 is positioned to sense the temperature of thetube's target portion 22 as it is heated by lasers 16 and 17. An opticalfilter (not shown) may be placed between the temperature sensor 28 andthe lasers 16 and 17 to eliminate reflection from the lasers 16 and 17into the sensor 28. A diameter sensor 30 is positioned to sense thediameter of the tube 10 at a portion of the tube 10 that has mostrecently been stretched. In this example, the diameter sensor 30 sensesthe diameter at a portion of the tube's leading portion 24 that is nearthe target portion 22. The system also includes a tension sensor 34 tomeasure the tension in the tube 10 caused by the difference in thepulling speed of the winding system 14 and the speed at which the tube10 is provided by the unwinding spool 12. A cooling device 32 ispositioned to cool a heated and stretched portion of the tube's leadingportion 24. The cooling of the heated portion of the tube 24 may preventthe tube 24 from stretching beyond a desired range as the longitudinalforce continues to be applied to the tube 24 by the winding system 14during the stretching process. The cooling device 32 may be placeddistal to the sensors 28 and 30, as shown in FIG. 1, or alternatively,may be placed between the lasers 16 and 17 and the sensors 28 and 30.

A controller 36 is connected to the temperature sensor 28, the diametersensor 30, and the tension sensor 34. The controller receives thetemperature readings of the heated portion 22 of the tube 10 from thetemperature sensor 28, cross-sectional diameter readings from thediameter sensor 30, and tension readings from the tension 34 sensor. Thecontroller is also connected to the unwinding spool 12, the windingsystem 14, the lasers 16 and 17, and the cooling device 32 to controlthe operation of each. Thus, the entire processing of the polymer tube10 to reduce the diameter of selected portions of the tube 10 may beunder computer control with feedback.

In the FIG. 1 example, the laser devices 16 and 17 may be solid-stateYag lasers that emit laser beams 18 with an emission frequency in arange with a high enough absorption coefficient to cause adequateheating of the polymer tube 10. Frequency ranges may be in the farinfrared, near infrared, visible range, and UV bands. In otherimplementations, the laser devices 16 and 17 may be a CO₂ laser, a diodelaser, or another suitable laser type. Alternatively, microwavegenerators emitting waves in the frequency bands from 2 GHz to 100 GHzmay be used. Like laser heating, heating with microwaves offersvolumetric heating that is fast and does not require contact with thepolymer tube 10. To heat the tube 10, microwaves may be directed throughwaveguides or a quasi-optical microwave beam, which is similar to alaser beam, may be used. The emission frequency of the laser beams 18may vary depending on the particular application and the type ofmaterial used to construct the tube 10. In the FIG. 1 example, thesystem has two lasers 16 and 17. In other implementations, the systemmay have only one laser or may have additional lasers to provide heat toadditional portions of the polymer tube 10.

The laser beams 18 may have a heating area that can range from as smallas a micron to as much as a centimeter and may be expanded or reduced inprecise amounts throughout the stretching process. By changing theheating area of the laser beams 18, the size of the tube's targetportion 22 may be varied during the stretching process. Further controlof the stretching process may be provided by changing the heat intensityof the laser beams emitted by the lasers 16 and 17. Increasing the heatintensity of the laser beams 18 will cause greater softening and greaterlongitudinal stretching of the polymer tube 10, assuming a constantlongitudinal force is being applied by the winding system 14. Likewise,lowering the heat intensity of the laser beams 18 will result in lesssoftening and thus less stretching.

The ability to vary the heat intensity of the laser beams 18 may also beused to change the molecular orientation, and thus the physicalcharacteristics, of the polymer tube 10. For example, if the polymertube 10 is stretched under elevated temperatures (a hot stretch), thestretched tube 10 will have a lower molecular orientation and will bemore elastic. If the polymer tube 10 is stretched after little or noheating (a cold stretch), the stretched tube 10 will have a highmolecular orientation and will be more stiff.

The winding spool system 14 may include conventional linear motor tocontrol the pulling force applied to the tube 10. In other examples, aclamp, jaw, or other suitable mechanism may be used to create thepulling force on the tube 10. Alternatively, the winding spool could bea pulley system through which the tube 10 is passed and placed in avertical alignment. A dead weight may then be secured to the tube'sleading end 26 to stretch the tube 10. In other implementations, theunwinding spool and motion system 12 may be replaced with anotherpulling device similar to winding system 14. For example, the unwindingspool may be a linear motor that can feed the polymer tube 10 to thelasers 16 and 17 for heating. In a system where the unwinding system 12and winding system 14 both include linear motors, the polymer tube 10may be stretched from either direction, or both directions, by changingthe direction and relative speeds of the linear motors. Alternatively,the unwinding and winding systems 12 and 14 could include two clamps tostretch the tube 10. Clamps may be particularly useful when only a smalllength of polymer tube 10 is being processed by the system, such as aparison for making a balloon.

The controller 36, which is connected to the unwinding system 18,winding system 20, and the lasers 16 and 17, may be used to preciselycontrol the polymer tube's cross-sectional diameter and molecularorientation. The controller 36 may also be used to control the speed ofthe overall stretching process. For example, by controlling the rate atwhich the polymer tube 10 is released from the unwinding system 12, itis possible to control the heat intensity and heating area of the lasers16 and 17, and the speed and longitudinal force applied by the windingsystem 14. The controller 36 may also cool the heated portion of thetube's leading end 24 with the cooling device 32. The cooling device maybe a nozzle that emits super-cooled nitrogen, or another suitable fluid.Alternatively, the cooling device may be a liquid or oil bath throughwhich the leading end 24 of the tube may pass after it is heated andstretched. In other implementations, the cooling device 32 may beomitted.

The controller 36 may further control the stretching process withfeedback provided by the temperature sensor 28, the diameter sensor 30,and the tension sensor 34. The temperature sensor 28 may be an infra-redsensor, thermistor, or other suitable type of sensor. Feedback providedto the controller 36 by the temperature sensor may allow the controller36 to continually adjust the intensity of the heat provided by thelasers 16 and 17. The diameter sensor 30 may measure the cross-sectionaldiameter of the polymer tube 10 ultrasonically, optically, or some othertechnique. Feedback may be provided to the controller through the sensor28 to allow the controller to continually adjust the parameters of thestretching process. The tension sensor may be of a conventionalthree-roller or on-line sensor. Alternatively, the tension sensor 34 maybe a torque sensor that is built into the control systems of most modernmotion control systems. For example, in implementations where thewinding system 14 is a servo motor, the motor may include a torquesensor that allows the torque of the motor, and thus the longitudinalforce applied to the tube 10, to be changed throughout the process. Inother implementations, the positions of the sensors 28, 30, and 34 maybe changed. Yet in other implementations, the sensors 28, 30, and 34 maybe omitted.

FIGS. 2A and 2B illustrate an exemplary process of heating andstretching a polymer tube using the systems and methods described inFIG. 1. FIGS. 2A and 2B illustrate the coordination of the unwindingsystem 12, the winding system 14, the lasers 16 and 17, and the coolingdevice 32 to heat and stretch the polymer tube 10 using the method ofFIG. 1. FIG. 2A shows the temperature of the tube's target portion 22and FIG. 2B shows the velocity at which the unwinding system 12 isproviding the tube 20 (Vunwinding) and the winding system 14 is pullingthe stretched tube 24 (Vwinding) during the stretching process.

Referring to FIG. 2A, the process begins by using the lasers to applyheat to the target portion of the tube at data point 200 until thetarget portion is heated to the stretching temperature at data point202. The stretching temperature is the temperature at which the tubebegins to soften and flow. During the heating of the tube's targetportion, the unwinding and winding system are operating at the samevelocities, as indicated by data points 204 and 206 in FIG. 2B. Thus,during the initial heating of the tube's target portion, there is notension in the tube and no stretching force is applied. In exampleswhere the lasers' heating area is equal to the area of the tube thatwill be stretched, the unwinding and winding systems will not beadvancing the tube, but rather the tube will be stationary. In exampleswhere the lasers' heating area is smaller than the desired stretchingarea of the tube, the unwinding and winding systems will be advancingthe tube at a specified rate of speed so that the lasers may heat theentire area of the tube that will be stretched.

Once the tube's target portion has been heated to the desiredtemperature, shown at data point 206, the velocity of the winding systemis increased and the velocity of the unwinding system is decreased toapply a longitudinal force to the tube and stretch the tube's targetportion. A constant force is applied by the pulling of the windingsystem using feedback from the tension sensor (shown in FIG. 1). Thewinding system continues to apply tension to the tube until the tube'starget portion is stretched to the desired cross-sectional diameter, asindicated by the diameter sensor (shown in FIG. 1). Once the desiredstretching is achieved, the velocity difference between the unwindingand winding systems is reduced, or in some examples eliminated, asindicated by data point 208. The unwinding and winding systems advancethe stretched portion of the tube to the cooling device (shown in FIG.1), which reduces the temperature of the tube's target portion below thestretching temperature, indicated by data point 210 in FIG. 2A. As thetube is advanced to cool the section that has just been stretched, a newportion of the tube to be stretched is advanced to the laser forheating. The process may then be repeated for the next section of thetube.

As the method is applied to subsequent portions of the tube, thecontroller may use the feedback provided by the diameter and tensionsensors to further fine-tune the stretching process. For example, thediameter sensor may indicate the amount of reduction in the diameter ofthe tube's target portion based on the amount of tension applied by thewinding system. Using the information provided by the amount of tensionapplied by the winding system may be varied to achieve the preciseamount of stretching desired. Alternatively, feedback from thetemperature sensor may be used to fine-tune the stretching process.Rather than adjusting the amount of tension applied by the windingsystem to vary the amount of stretching, the amount of stretching may beincreased or decreased by the changing the amount of heat applied by thelasers, and thus, the temperature of the tube's target portion.

In the example of FIGS. 2A and 2B, the heating and stretching of thepolymeric tube are not performed simultaneously. In other words, thetarget portion of the polymer tube is heated to the desired stretchingtemperature before the velocity of the winding system is increased tostretch the tube's target portion. In other examples, the target portionof the tube may be simultaneously heated and stretched. In theseexamples, equilibrium may be achieved between the operational velocitiesof the winding and unwinding spools and the heat energy provided bylasers. In a state of equilibrium, the lasers apply a constant amount ofheat to the tube and the unwinding and winding spools both operate at aconstant velocity, with the winding spool velocity being greater thanthe velocity of the unwinding spool. The difference in velocity createsa constant tension in the tube, and because the heat applied to the tubeis constant, the tube is stretched to the same dimension throughout theprocess.

Equilibrium may be achieved through the use of the controller 36 and thefeedback provided by sensors 28, 30, and 34 (shown in FIG. 1). Toachieve an optimal result, the controller may be provided withalgorithms to automatically execute and optimization method. Aquasi-Newtonian non-linear optimization approach, such as theBroyden-Fletcher-Goldfarb-Shanno, is recommended.

FIGS. 3-8 are successive diagrams of an elongate tube, or parison, as itis processed to form a balloon for a balloon catheter. Briefly and byway of overview, the illustrated process includes heating and stretchinga first portion of the parison to create a first cone section and afirst waist section for the balloon. Next, a second portion of theparison is heated and stretched to form a second cone section and secondwaist section for the balloon. Between these two heated and stretchedportions of the parison is a third portion, which is radially expanded,for example, in a blow-molding chamber, to form a body portion of theballoon.

The process illustrated in FIGS. 3-8 facilitates the manufacture ofballoons with high hoop ratios, for example a ratio of 5, that also havehoops strengths suitable for use in cardiac procedures, such as a PTCA.The precise heating and stretching provided by lasers allows asignificant reduction in the wall thickness of the cone and waistsections of the parison without a corresponding reduction in the wallthickness of the body section. Because the wall thickness of the bodysection is maintained during the manufacture of the parison, the parisonmay be blow molded to large diameters, such as 9 millimeters, withoutcompromising its hoop strength. Moreover, the method permits a reductionin the diameter and wall thickness of the balloon's waist sections toprovide greater flexibility and a smaller crossing profile.

Now, turning to a more detailed description of the process, FIG. 3 showsa cross-sectional view, along a longitudinal plane, of a parison 40 thathas a first end 42, a second end 44, and a body section 46 between thefirst and second ends 40 and 42. A first portion 48 is formed into afirst cone section 50 and a first waist section 52 (shown in FIG. 3) byheating the portion 48 with a laser, as indicated by the arrows. Thefirst portion 48 extends from the first end 42 of the parison 40 to anedge 47 of the body section 46 nearest the first end 42. Once the firstportion 48 is heated, a pulling force is applied to the first end 42 andstretches the now heated portion 48 of the parison 40 to form the firstcone section 50 and the first waist section 52 shown in FIG. 4. Thepulling force may be applied by, for example, the winding system 14shown in FIG. 1 or by some other suitable mechanism.

The cone and waist sections 50 and 52 may be formed in a number ofdifferent ways using the heating and stretching method of FIG. 1. Forexample, a laser capable of emitting a laser beam that heats only asmall longitudinal section of the first portion 48 may be used to varythe amount of heat applied to the different sections of the firstportion 48 during the stretching process. In one example, the firstportion 48 is formed by applying heat with a laser to a section of thefirst portion 48 adjacent to the body portion 46 and moving the laserdevice, and thus the section of the first portion 48 that is heated,toward the first end 42 while the first portion 48 is stretched by apulling device at the first end 42. In this example, the cone section 50is formed by gradually increasing the amount of heat applied by thelaser as it moves away from the body portion 46. The gradual increase inheat applied to the first portion 48 causes increased stretching and acorresponding reduction in the diameter of the cone section 50 as shownin FIG. 4. Once the cone section 50 is formed, the level of heat appliedby the laser is maintained as the rest of the first portion 48 isstretched to create the waist portion 52.

Next, referring to FIG. 5, the second end 44 of the parison 40 is heatedand stretched to form a second cone section 56 and second waist section58 (shown in FIG. 6). The second end 44 is formed by heating a secondportion 54 of the parison 40 with a laser as indicated by the arrows.The second portion 54 extends from the second end 44 to an edge 45 ofthe body section 46 nearest the second end 44. After the portion 54 isheated, a pulling device pulls the second end 44 and stretches theportion 54 of the parison 40 to form the second cone section 56 and thesecond waist section 58 shown in FIG. 6. The second portion 54 may beheated and stretched in a manner similar to the first portion 48,described previously.

In the example of FIGS. 3-6, the parison 40 was of a uniform lengthbefore it was heated and stretched. In other examples, the parison 40may be pre-processed using a laser ablation or grinding process toremove material in the locations where a thinning of the wall thicknessis required. Similarly, laser ablation may be used as a post-processingstep to fine-tune the diameter of the parison.

Once the parison 40 is formed to the configuration shown in FIG. 6, thebody portion 46 of the parison may be radially expanded to create aballoon. FIGS. 7-8 illustrate the radial expansion of the formed parison40 in a blow-molding chamber 60. As is conventional in the art, theparison 40 is placed in the chamber 60 as shown in FIG. 7. The chamber60 is heated to a temperature of 70 to 120 degrees Celsius or moredepending upon the parison material and the desired properties of theballoon. Once heated, a pressurized fluid is introduced into an internalchamber 62 of the formed parison 40. The pressure of the fluid causesthe parison's body portion 46 to expand as shown in FIG. 8. To achieveexpansion of the body section 46 during the blow-mold process, and notjust expansion of the cone sections 50 and 56, the chamber 60 may bemade out a transparent glass material, such as ZnSe, to allow the bodyportion 46 to to be heated by a laser or microwave. Alternatively, thechamber 60 may be heated to indirectly heat the desired portions of theformed parison 40. For example, the chamber 60 could be divided into acentral section that may be heated to heat the body portion 46 and coldsections that cool the cone sections 50 and 56.

FIG. 9 is a cross-sectional view, along a longitudinal plane, of adistal portion of a balloon catheter 100 with a balloon 102. The FIG. 9balloon catheter 100 provides an example of the dimensions of a ballooncatheter manufactured using the laser heating and stretching system andmethods described in FIGS. 1-8. These methods allow the manufacture ofballoons that have an inflated outer diameter greater than about sixmillimeters for use on a balloon catheter having a 0.014″ guide wire,and that are of a suitable hoop strength for use in cardiac proceduresand other similar procedures throughout the body.

The catheter 100 includes an elongate shaft 103 that extends through thelongitudinal center of the balloon 102. The balloon 102 has a proximalwaist section 104, a body portion 106, and a distal waist section 108. Aguide wire 110 extends longitudinally through a lumen in the cathetershaft 103 so that the catheter 100 may be guided through vessels in thebody. The balloon may be constructed of Nylon 12, PET, PEBAX, PEEK, or asimilar material.

In the FIG. 9 example, the balloon catheter's guide wire 110 may have adiameter of 0.014 inches. During a procedure, the guide wire lumen inthe catheter's shaft 103 must allow the guide wire 110 to be moved in alongitudinal direction through the lumen; however, the lumen must alsobe sized appropriately to provide sufficient control of the catheterduring a procedure. To achieve these goals, in this example, the innerdiameter of the catheter shaft 103 (the guide wire lumen in thisexample) is slightly larger than the outer diameter of the guide wire soas to appropriately accommodate the guide wire 110 during a procedure.Typically, this requires the inner diameter of lumen through which theguide wire 110 extends to be approximately two thousandths of an inchlarger than the outer diameter of the guide wire. In other examples, thediameter of the guide wire 110 and the inner diameter of the cathetershaft 110 may be larger or smaller depending upon the application andthe preference of the physician performing the procedure.

In the FIG. 9 example, the balloon 102 may have an inflated diameter ofmore than 6 millimeters, for example 9 millimeters, as indicated bydimension A. The inflated diameter is the diameter of the body portion106 of the balloon 102 when it is inflated during a procedure.

The balloon also includes waist sections 104 and 108 that are typicallywelded to the catheter shaft 103 and secure the balloon 102 attaches tothe catheter shaft 103 at the balloon's waist sections 104 and 108. Theinner waist diameter is the inside diameter of the waist sections 104and 108 of the balloon 102, and is slightly larger than the outerdiameter of the catheter's shaft 103. In this example, the balloon mayhave an inner waist diameter (indicated by dimension B) that ranges from0.022 inches, which is typical for a catheter using a 0.014″ guide wire,to 0.028 inches. In other examples, the inner diameter may be increasedor decreased depending on the size of the catheter shaft 103. In anexample where the inflated body portion 106 of the balloon 102(dimension A) is seven millimeters and the inner waist diameter is 0.022inches (dimension B), the ratio between these dimensions isapproximately 12.5 to 1. In an example where the inflated diameter ofthe balloon is increased to 9 millimeters, the ratio increases toapproximately 16.1 to 1. As the dimensions A and B either increase ordecrease in other examples, the ratio between the inflated body portion106 and the inner waist diameter may vary.

FIG. 10 is a conceptual diagram of a balloon 150 for a balloon catheter,where the balloon 150 has been manufactured using variations of theheating and stretching processes previously described. In variousimplementation, the balloon 150 may be made of a single polymericmaterial, such as PET or PEBAX. The diagram shows a side view of theballoon 150 with markings on the balloon's body portion 152 thatillustrate the molecular orientation of three regions 154, 156, and 158that make up the body portion 152. In this example, the balloon hasthree regions 154, 156, and 158 that each make up a third of the bodyportion's length. Using the laser heating and stretching methods, thethree regions 154, 156, and 158 may be manufactured with differentmolecular orientations, and thus different physical characteristics, byvarying the amount of heat applied to the regions by the laser duringthe stretching process. The variation in molecular orientation over thissmall area, approximately 1-2 centimeters in one example, is possibledue to the high level of control over the heating area provided bylasers.

In the FIG. 10 example, the first and third regions 154 and 158 have ahigh molecular orientation as compared to the second region 156, whichis located between the first and third regions 154 and 158. Thedifference in the orientations of the regions 154, 156, and 158 isaccomplished by increasing the heating intensity of the laser deviceduring the stretch of the second region 156 as compared to the heatintensity applied during the stretch of the first and third portions 154and 158. The increase in heat during the stretching of the second region156 causes the region 156 to experience a lower molecular orientation,and thus become less compliant than the first and third regions 154 and158 that were stretched under lower temperatures. Thus, when inflated,the second region 156 may have a greater inflation diameter as comparedto the first and third regions 154 and 158. This may be useful inapplications such as in various cardiac procedures, in renal procedures,or in other vascular procedures. In other implementations, the bodyportion 152 may have more or fewer regions than shown in the FIG. 10example, depending upon the size of the balloon and the desiredapplication.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. A method of manufacturing a balloon for a balloon catheter, themethod comprising: heating and longitudinally stretching a first portionof an elongate polymeric tube to form a first reduced diameter portionof the tube that serves as a first end portion for the balloon; heatingand longitudinally stretching a second portion of the tube to form asecond reduced diameter portion of the tube that serves as a second endportion for the balloon that is opposite the first end portion, thereremaining a body portion located between the first and second endportions; and expanding the body portion of the tube radially to formthe balloon.
 2. The method of claim 1 wherein the heating of the firstand second portions is performed by a laser.
 3. The method of claim 2wherein the laser emits a beam in the infrared frequency range to heatthe first and second portions.
 4. The method of claim 1 wherein beforethe method is performed the elongate polymeric tube has a uniformdiameter.
 5. The method of claim 1 wherein the formed balloon has aninflatable body portion with sufficient hoop strength for use in anangioplasty procedure.
 6. The method of claim 5 wherein the balloon'sinflated outer diameter is more than about 7 millimeters.
 7. The methodof claim 6 wherein the balloon's inflated outer diameter is about 9millimeters.
 8. The method of claim 1 wherein the first end portion ofthe balloon includes a first waist section and the second end portion ofthe balloon includes a second waist section, the first and second waistsections having an inner diameter such that the balloon may be affixedto a catheter shaft that has an inner lumen sized appropriately toaccommodate a guide wire having a diameter of at most about 0.014inches.
 9. The method of claim 1 wherein the first end portion of theballoon includes a first waist section and the second end portion of theballoon includes a second waist section, the first and second waistsections having an inner diameter of no more than 0.028 inches.
 10. Themethod of claim 1 wherein the formed balloon has an inflatable bodyportion that has a longitudinal length suitable for use in anangioplasty procedure.
 11. The method of claim 1 wherein the formedballoon has an inflatable body portion that has a longitudinal length ofno more than about 30 millimeters.
 12. A catheter comprising: anelongate shaft having a lumen that extends longitudinally through theshaft, the lumen sized appropriately to accommodate a guide wire havinga diameter of at most about 0.014 inches; and an inflatable polymericballoon affixed circumferentially about the shaft near the distal end ofthe shaft, the balloon having a body portion with an inflated outerdiameter of more than about 7 millimeters.
 13. The catheter of claim 12wherein the balloon's body portion has an inflated outer diameter of 9millimeters.
 14. The catheter of claim 12 wherein the balloon has aninflatable body portion suitable for use in an angioplasty procedure.15. The catheter of claim 12 wherein the balloon has a first end portionthat includes a first waist section and a second end portion thatincludes a second waist section, the first and second waist sectionshaving an inner diameter of no more than about 0.028 inches.
 16. Thecatheter of claim 12 wherein the balloon is formed by heating andlongitudinally stretching a first portion of an elongate polymeric tubeto form a first reduced diameter portion of the tube that serves as afirst end portion for the balloon; heating and longitudinally stretchinga second portion of the tube to form a second reduced diameter portionof the tube that serves as a second end portion for the balloon that isopposite the first end portion, there remaining the body portion locatedbetween the first and second end portions; and expanding the bodyportion of the tube radially to form the balloon.
 17. The catheter ofclaim 16 wherein before the balloon is formed the elongate polymerictube has a uniform diameter.
 18. The catheter of claim 16 wherein theheating of the first and second portions is performed by a laser. 19.The catheter of claim 16 wherein the laser emits a beam in the infraredfrequency range to heat the first and second portions.
 20. An inflatablepolymeric balloon for a balloon catheter, the balloon comprising: awaist portion having an inner diameter that fits circumferentiallyaround and is affixable to an elongate shaft that has an inner lumensized appropriately to accommodate a guide wire having a diameter of atmost about 0.014 inches; and a body portion that has an inflated outerdiameter, the ratio of the outer diameter of the body portion to theinner diameter of the waist portion being more than about 12.5 to
 1. 21.The balloon of claim 20 wherein the inner diameter of the waist portionis no more than about 0.028 inches.
 22. The balloon of claim 20 whereinthe balloon has an inflatable body portion with sufficient hoop strengthfor use in an angioplasty procedure.
 23. The balloon of claim 20 whereinthe balloon has an inflated outer diameter of more than about 7millimeters.
 24. The balloon of claim 23 wherein the balloon has aninflated outer diameter of about 9 millimeters.
 25. The balloon of claim20 wherein the elongate polymeric tube has a uniform diameter before theheating and stretching of the portion of the tube.
 26. The balloon ofclaim 20 wherein the waist portion of the balloon is formed by heatingand longitudinally stretching a portion of an elongate polymeric tube.27. The balloon of claim 26 wherein the heating of the portion of thetube is performed by a laser.
 28. The balloon of claim 27 wherein thelaser emits a beam in the infrared frequency range to heat the portionof the tube.
 29. A method of processing an elongate polymeric materialfor use in a medical device that is placed inside a body, the methodcomprising: heating a portion of the polymeric material with a laserwhile longitudinally stretching the portion of the polymeric material.30. The method of claim 29 wherein the laser emits a beam in theinfrared frequency range to heat the polymeric material.
 31. The methodof claim 29 wherein the heating area of the laser is no more than abouttwo millimeters.
 32. The method of claim 29 further comprising coolingthe heated portion of the polymeric material after it has beenlongitudinally stretched to the desired dimension.
 33. The method ofclaim 29 wherein a control system controls the heating and stretching ofthe polymeric material.
 34. The method of claim 29 wherein the polymericmaterial is Nylon 12, PEBAX, PET, or PEEK.
 35. An inflatable balloon fora balloon catheter, the balloon being constructed of a single polymericmaterial and having a first region wherein the polymeric material isoriented in a fashion that results from the balloon's body portion beingstretched while being heated by a laser, and the balloon further havinga second region wherein the polymeric material is oriented differentlyfrom the first region.
 36. The balloon of claim 35 wherein the balloonhas an inflatable body portion that has a longitudinal length suitablefor use in an angioplasty procedure.
 37. The balloon of claim 35 whereinthe balloon has an inflatable body portion that has a longitudinallength of at most about 30 millimeters.
 38. The balloon of claim 35wherein the laser emits a beam in the infrared frequency range to heatthe polymeric material.
 39. The balloon of claim 35 wherein thepolymeric material is Nylon 12, PEBAX, PET, or PEEK.